Product Portfolio Development &
Enhancement
Product Development Partnership
From conceptualization to market launch, we offer a full spectrum of services, ensuring seamless support across all stages of drug development.Our expertise lies in identifying challenges early on during the product development stage, potentially saving time and resources, and accelerating the overall development timeline.We help upgrade the existing product portfolio for market expansion and identifying partners for out-licensing/in-licensing. As a versatile partner, we encourage pharmaceutical companies to exploit our services for various development needs. Our flexibility ensures a customized and efficient collaboration. Evaluate co-development, co-marketing agreements, or licensing deals to enhance your products market position.
We support the following activities in formulation development program.
| Product Selection and Commercial strategy | Reference Product & Bio strength Selection |
| Building Target Product Profile | Formulation Development Needs |
| Analytical Method Development Needs | Pharmaceutical Sourcing |
| Protocol and Report Writing | Product Development Report Writing |
| Justification for Bio-waivers | Regulatory Compliance |
| Scientific Advice Meetings | Project Management |
Due Diligence
Conducting due diligence on drug product dossier or licenses is a critical process, especially in the context of transfer of ownership, mergers and business acquisitions, licensing agreements, or partnerships within the pharmaceutical industry. Due Diligence of existing products for new markets is a strategic approach to identify and address potential issues, ultimately facilitating faster regulatory approvals and market expansion. The objective is to thoroughly assess the quality, completeness, and compliance of the dossier before making business decisions. We perform a 360 degree due diligence on drug product dossiers with a multidisciplinary approach involving regulatory, scientific, legal, and financial expertise.
Engage us to
| Assess regulatory compliance of target market | Identify and assess potential regulatory risk |
| Investigate the regulatory history of product | Evaluate the financial implications |
| Scrutinize the integrity of data | Conform intellectual property status |
| Assess legal aspects, licensing agreements, contractual obligations | Evaluate further market expansion |
| Assess the manufacturing process | Verify quality control and assurance procedures align with regulatory requirements |
Life Cycle Management
Typically, life cycle management involves entering new geographic markets, label expansions, obtaining additional indications, seeking additional approvals for different patient populations and exploring novel formulations, new dosage forms, line extensions, combination therapies to maximize the market potential. Plan post approval studies strategically to unlock the additional value of your licensed products for a broader market.
We offer life cycle management services including entering new geographic markets and exploring novel formulations, new dosage forms, line extensions to maximize the products market potential. We manage following post-market compliance activities for our business partners.
| Renewals | New Indications |
| Variations | Alternate Site Identification and qualification |
| Sunset Clause Applications | Alternate sourcing of raw materials |
| Extensions | Optimizing Cost of Product |
| New Dosage Forms | Expansion to other markets |
Regulatory Advisory and Oversight
We provide insights into regional and global regulatory requirements, helping companies plan their development pathways accordingly. We assist in formulating a comprehensive regulatory strategy that is aligned with the company’s overall business objectives. We engage with your team in a multidisciplinary technical review from development to launch of the product. The goal is to ensure that the product is developed in a technically sound manner, meeting both regulatory requirements and industry best practices.
| Technical Document Writing and Review | Drafting convincing scientific justifications |
| Authoring CTD Module 1 to 5 | National to CTD formats/eCTD conversion |
| Quality Overall Summary | MAA/ANDA/ANDS/DMF/CEP/ IMPD/CTA/IND |
| Clinical and Non Clinical Overviews/Summaries | Gap Analysis and Upgradation of legacy Product Dossiers |
Manufacturing Support
The pharmaceutical manufacturing is witnessing innovation in equipment, products and processes. The pharma industry has always faced various operational challenges that increase overheads and complexity to an already competitive marketplace.
Traditional ways of overcoming operational challenges like increasing investment, replacing equipment or hiring professionals are no longer sufficient. A pharma manufacturer needs to devise innovative ways for faster development and quality enhancement throughout its production processes.
Maira can help you with the mitigation of operational challenges by offering comprehensive solutions involving
- Use of Process Automation Techniques
- Optimization of Energy Utilization
- Preventing Unplanned Downtime
- Reducing Process Variability
- Implementation of a Robust Plant Maintenance Management System
- Manpower Mapping and Optimization
- Personnel Training
Contact us for
| Process Optimization & Productivity Improvement | Sourcing of Raw Material & Packaging Material |
| Capacity and Manpower Optimization | Sourcing of Finished Product |
| Automation | Procurement of Process Equipment |
| Identification of Manufacturing Facilities | Engineering Projects and Plant Design |
| Due Diligence of Facilities | Quality Improvement |
| Greenfield and Brown field project Management | Technology Transfers |
Quality Compliance
Maira offers comprehensive compliance solutions:
- Prepare and manage required SOPs for cGMP compliance
- Third party audits of API/Excipients/Packaging materials
- Identification & Qualification of Manufacturing Facilities for Drug Product
- Sourcing and Vendor Qualification
- Prepare and execute Quality and Technical Agreements
- Designing Protocols and Reports for key activities
- Transfer of Technology and Contract Manufacturing
- Analytical Method Transfers